New FDA Guidance Offers Additional Info On eStar Submissions
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.
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The US agency’s new guidance doc lays bare the types of submissions device and drug makers should send to the agency electronically.
Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.
Through home and community-based services, Medicaid beneficiaries can receive support and tap into program services from home.